Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-05 @ 5:58 PM
Study NCT ID:
NCT03835832
Status:
COMPLETED
Last Update Posted:
2020-07-16
First Post:
2019-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-Assessment Tuberculin Skin Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-14', 'studyFirstSubmitDate': '2019-02-07', 'studyFirstSubmitQcDate': '2019-02-07', 'lastUpdatePostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'self-assessment versus nurse reading', 'timeFrame': '6 months', 'description': 'this study will assess the sensitivity of this new innovative method for reading TST'}, {'measure': 'self-assessment versus nurse reading', 'timeFrame': '6 months', 'description': 'this study will assess the specificity of this new innovative method for reading TST'}, {'measure': 'self-assessment versus nurse reading', 'timeFrame': '6 months', 'description': 'this study will assess the positive predictive value (PPV) of this new innovative method for reading TST'}, {'measure': 'self-assessment versus nurse reading', 'timeFrame': '6 months', 'description': 'this study will assess the negative predictive value (NPV) of this new innovative method for reading TST'}], 'secondaryOutcomes': [{'measure': "In house questionnaire to assess the patients' satisfaction of reading TST by themselves", 'timeFrame': '6 months', 'description': "Evaluation of patients' satisfaction in self- assessment TST by using questionnaires"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tuberculin skin test', 'latent TB infection', 'HIV/TB co-infected participants', 'Sensitivity', 'Specificity', 'positive predictive value (PPV)', 'negative predictive value (NPV)'], 'conditions': ['Tuberculin Skin Test']}, 'descriptionModule': {'briefSummary': 'The research team/investigator/nurse/professional health care workers will teach the participants how to read the results for TST test. The investigator will compare the reading results done by the participants to the results read by the nurses.', 'detailedDescription': 'This is a cross-sectional study of HIV-infected patients from 2 HIV clinics in Bangkok: HIV-NAT, Thai Red Cross AIDS Research Centre and Taksin Hospital. Research team/investigator/nurse/professional health care workers will assess whether the reading of TST test between the participants and the nurses are the same or not. The investigator and team believe that the readings of the TST tests between the participants and the nurses will be the same. If the investigator and team hypothesis is correct, then this will lessen the workload of the nurses and reduce the number of times the participants have to come to the clinic to see the nurses and the doctors. This is a pilot study to test this innovative method to teach the participants to read the TST results by themselves. If this technique is successful, then the investigator and team can expand the method to other hospitals in Thailand as well as in the region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-infected adults with documented HIV diagnosis who do not have any signs or symptoms of active TB.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Documented HIV-1 infection\n2. Aged ≥18 years old\n3. No sign and symptom of active TB\n\nExclusion Criteria:\n\n1\\. Refuse to read TST by themselves'}, 'identificationModule': {'nctId': 'NCT03835832', 'acronym': 'ISAT', 'briefTitle': 'Self-Assessment Tuberculin Skin Test', 'organization': {'class': 'OTHER', 'fullName': 'The HIV Netherlands Australia Thailand Research Collaboration'}, 'officialTitle': 'Innovation of Self-Assessment Tuberculin Skin Test for Latent TB Screening in HIV Patients', 'orgStudyIdInfo': {'id': 'HIV-NAT 260'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV-infected participants who receive TST test', 'description': "0.1 ml of tuberculin purified protein derivative will be intra-dermally inoculated on the forearm of the HIV-infected participants. They will learn how to interpret the results of the TST test. When they return to the clinic, the nurse will also interpret the results of the TST test. The results from the participants will be compared to the nurses' interpretation. We will assess the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the innovative method.", 'interventionNames': ['Other: The participants do not receive any intervention for this study']}], 'interventions': [{'name': 'The participants do not receive any intervention for this study', 'type': 'OTHER', 'description': 'The participants do not receive any intervention for this study', 'armGroupLabels': ['HIV-infected participants who receive TST test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'HIV-NAT, Thai Red Cross AIDS Research Centre', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10600', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Taksin Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Sivaporn Gatechompol, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HIV-NAT, Thai Red Cross - AIDS Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The HIV Netherlands Australia Thailand Research Collaboration', 'class': 'OTHER'}, 'collaborators': [{'name': 'Taksin Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}